Chagas Disease, Colchicine Resistance
Conditions
Keywords
fibrosis, Inflammation
Brief summary
This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease. Forty patients will receive colchicine while twenty patients will receive placebo
Detailed description
Chagas disease is considered one of the main cause of dilated cardiomyopathy in Latin America. The histopathological characteristics of Chagas' disease are the presence of myocarditis, destruction of heart fibers, and severe myocardial fibrosis. Colchicine had a protective effect on myocardium, indicated by decreased interstitial myocardial fibrosis and attenuated myocardial inflammation. It is an inflammatory cause of cardiomyopathy and myocardial fibrosis is the hallmark of this disease. Colchicine is a drug used in inflammatory diseases, and could also act on myocardial remodeling interfering in the synthesis of collagen
Interventions
DRUGColchicine 0.5 MG twice day for one year
placebo twice day for one year
DRUGPlacebo Oral Tablet
placebo twice day for one year
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical and serological diagnosis of Chagas´disease ( Stage B1) * Must be able to swallow tablets
Exclusion criteria
* myocardial infarction or coronary artery disease, * diabetes mellitus, * valvular disease, * creatinine clearance \<30 ml / kg / min * contraindication to perform cardiac magnetic resonance imaging * use of angiotensin converting enzyme inhibitors, angiotensin II receptor blockers and aldosterone blockers * previous use of benzonidazole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging | 1 year | myocardial edema quantified in grams or percent of LV mass, myocardial hyperaemia quantified in grams or percent of LV mass |
| Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging | 1 year | myocardial fibrosis quantified in grams or percent of LV mass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10 | 1 year | interleukin-1, interleukin-6, interleukin-8, interleukin-10, ELISA (pg/mL) |
| Effect of colchicine on inflammatory marker such as TNF-α | 1 year | TNF-α ELISA (pg/mL) |
| Effect of colchicine on inflammatory marker such as interferon-gama | 1 year | Interferon -gama ELISA (pg/mL) |
| Effect of colchicine on T Cruzi polymerase chain reaction | 1 year | 7500 PCR-Real time System (Life Technologies) |
Countries
Brazil
Contacts
Primary ContactFabio Fernandes, MD, PHD
Backup ContactPaula Buck, PHD
Outcome results
None listed